# K121893: Stryker SDC3 HD Information Management System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Sep 5, 2012 after 68 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931783 (1993). 10 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022393: Merdoc System, Stryker Endoscopy (2003) Summary page 4.

## Most influential descendants
- K160332: Stryker SDC3 HD Information Management System with Wireless Device Control Capability (2016), 12 descendants of its own
- K181258: ConnectedOR Hub with Device and Voice Control (2018), 10 descendants of its own
- K192172: Connected OR Hub with Device and Voice Control (2019), 9 descendants of its own
- K201434: Connected OR Hub with Voice Control, Connected OR Hub with Device Control (2020), 8 descendants of its own
- K212055: Connected OR Hub with Device and Voice Control (2021), 6 descendants of its own

## Indications for use
The Stryker SDC3 HD Information Management System (SDC3) is intended for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Source page: https://510kreport.com/device/K121893
Methodology: https://510kreport.com/methodology